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Online Resumes with "Study Management"
You shouldn't have to read my entire resume to know I'm the one!
I absolutely enjoy what I do and look forward to work every week. I know there will be challenges and problems that my team and I will have to solve. I enjoy this career because every day is different. Every study requires a different amount of care and expertise/experience. I love the organization that comes with this career. I love having my own studies and organize documents according to company SOP as well as my own way...
Ideal Companies: Any Biopharma Company (start-up, or young companies) in Phase 1 or 2 of their studies
Tags for this Online Resume: Instant Messaging, Data Analysis, Document Management, Good Clinical Practices, Good Laboratory Practices, Management, Medical, Medical Terminology, Microsoft, Microsoft Excel, Data Entry, Site Feasibility, Trial Master File Audit, Trial Master File, Routine Monitoring Visits, Bilingual, IWRS Systems, DSMB, analysis of PK data from different generations of Japanese subjects, Receiving Plasma samples and storing them in freezers, Urine collection and UA testing, Phlobotemy, ECGs, Dosing, Writing Visit Reports, Query data sheets, Resolving Queries within the SOP allotted time frame, Pippetting Fluids and shipping off with appropriate courier., CRA visit matrixes, Reporting numbers and statistics to Project Manager and Operations Manager, Reviewing Source Documents and making original source documents according to procedures in the protocol, Protocol review sessions, QA sessions daily with a volunteer from each department to go over daily data and tasks to make sure none were missed, Call subjects and perform AE checks according to timelines on protocol, Send critical documents to sites directly or through CRAs as demanded., Make progress matrices of site visits and site reports, Send reminder emails for upcoming visits for CRAs and internal deliverables, Coder
Clinical Research
ACCOMPLISHMENTS * Worked with 50 different sponsor and CRO companies on various GI studies * Managed Bunion investigational study with 300 patients. * Three FDA audits without 483. * Met all recruitment targets within required study timeframe * Managed regulatory binder for studies, post start-up * In depth knowledge of Microsoft packages ( Word, Excel and power point) Experienced with Oracle, Inform, Medidata eDC programs ...
Tags for this Online Resume: Oncology, Research, Clinical Research, Microsoft PowerPoint, Microsoft Word, Oracle, Recruiting, Staffing & Recruitment, Computer Aided Software Engineering, Good Clinical Practices
Director of Quality - 20 Years of Experience - Near 91709
SUMMARY OF QUALIFICATIONS * Over twenty years of experience managing regulatory affairs (RA)/quality assurance (QA), quality control (QC)/research & development (R&D) departments in pharmaceutical, medical device and dietary supplement manufacturing industries. Implemented Quality Management Systems meeting domestic and international regulatory requirements and ISO registration. Reviewed pre-clinical, clinical and pharmacok...
Ideal Companies: Pharmaceutical, Medical Device, Biomedical
Tags for this Online Resume: Quality, Quality Assurance, Quality Control, Manufacturing, Regulatory Affairs, Microbiological Testing, Test, ISO, Pharmaceutical, ADA
Quality Coordinator
Professional Summary: * Certified clinical research professional with nearly 10 years of clinical research experience in the medical device industry. I have a wide range of knowledge with site and study management having worked as an In-house/Field CRA, Lead CRA and Clinical Trial Assistant. * Conducting: Qualification, Initiation and Close-Out monitoring visits for pre and post-market trials. * Start-up activities for both...
Tags for this Online Resume: Documentation, Management, Data Management, Budgeting, Clinical Operations, Clinical Research, Collection, Compliance, Contract Negotiations, Distribution
Clinical Research - 15 Years of Experience - Near 54901
Summary Seasoned director of clinical operation and project management with over 18 years' experience in local and global CRO and pharmaceutical industry, specializing in phase I, BA/BE start-up operations. Complete and solid understanding of business priorities, genuine team player committed to managing operations and projects efficiently and without flaws, while contributing to revenue producing activities. Serve as a key...
Tags for this Online Resume: Clinical Research, Research, Dermatology, Support, Clinical Management, Documentation, Management, Ophthalmology, Outsourcing, Cardiology
Director of Human Resources - 15 Years of Experience - Near 91604
PROFILE Successful senior leadership experience as a change agent, team builder and process advocate in world-class corporate HR environments. Diverse background in strategic planning, risk management, organizational development, employee benefits and strategic planning in growth-oriented business settings. Highly skilled in building effective teams, facilitating large-scale transitions, redesigning business processes, esta...
Ideal Companies: Entertainment, Hotels, Hospitals
Tags for this Online Resume: Compensation, Consulting, Labor Relations, Nursing, Planning, Succession Planning, Reinsurance, Diversity, HR, Human Resources
Clinical Research
Ideal Companies: Cabezon
Tags for this Online Resume: Cancer, Coding, Coding Letters, CT, Data Analysis, Health Insurance, Health Insurance Portability And Accountability Act, Insurance, Management, Microsoft PowerPoint
Clinical Data Management
Tags for this Online Resume: Cancer, Coding, Coding Letters, CT, Data Analysis, Health Insurance, Health Insurance Portability And Accountability Act, Insurance, Management, Microsoft PowerPoint
Sr. Clinical Research Associate - 22 years Experience - remote - Austin, TX
A top-performing Senior Clinical Research Associate with extensive experience in clinical research, GCP, ICH, Regulatory, and clinical site management/monitoring. Solid background in critical care nursing for in-depth understanding of medical terminology for records review. Highly skilled in spearheading internal teams through clinical research and document management to ensure accuracy and adherence with study specific str...
Ideal Companies: Pharmaceutical, Biotech, Medical Device, CRO
Tags for this Online Resume: Clinical Research, Management, Protocol, Research, Documentation, Medical, Allergy, Monitoring, Reporting Tools, Cardiology, clinical, trial, gcp, protocol, pharmaceutical, regulatory, medical device, CNS, EDC, contract, remote, CRO
Clinical Data Management - 4 Years of Experience
A health care professional with about 6 years of experience in research management, data collection entry and analysis, Clinical Research, Administrative operations as well as good experience in medical records * Proficient with healthcare administration functions, including claims processing, eligibility verification, provider verification and preauthorization and HIPAA regulations * Obtain relevant medical information fr...
Tags for this Online Resume: Regulatory Affairs, Research, Audit, Benefits, Clinical Research, Collection, Distribution, Document Review, Health Insurance Portability And Accountability Act, ICD-9
Project Manager - 20 Years of Experience
I am a PMI certified Project Management Professional (PMP) with over 30 years project management experience, with both government and as an independent consultant. I retired from NASA after 36 years with the agency. This includes a solid record of system engineering and project management with the Space Shuttle, Space Station, Tracking and Data Relay Satellite System (TDRSS). Since leaving NASA, I’ve been a Project Manageme...
Ideal Companies: Electrolux, Siemens Corporation, Duke Energy, Northrop Grumman, L-3 Communications, Stinger Ghaffarian Technologies (SGT), Booz Allen Hamilton, SAIC, Lockheed Martin, The Analytic Sciences Corporation (TASC), Southwest Research Institute, General Dynamics, Aerospace Corporation, Arctic Slope Regional Corporation (ASRC), General Electric, Honeywell, BAE Systems, Rockwell Collins, Harris, MITRE Corporation, Teledyne Brown Engineering, Chenega Federal Systems, B/E Aerospace, Eaton Corporation, ST Engineering, Orbital Sciences Corporation, Ultra Electronics, Ball Aerospace, Marshall Aerospace, ITT, Oceaneering, Applied Services Aerospace, Raytheon Company, Engineering Management Concept, Boeing Company, Arinc, Wyle Laboratories, BAI Aerosystems, EADS North America, Emergent Space Technologies, Hawk Corporation, ATK, Integrative Designs, Carolina Unmanned Vehicles, Piedmont Facilities Service, UTC Aerospace Systems, Goodrich Aerospace, Dynetics, Optical Sciences Corporation, Ionetrics
Tags for this Online Resume: Project Management, Microsoft Office, Project Planning and Development, Budget and Schedule Development, Project Management Professional, PMP, Program Management, Program Management Office, Project Management Office, Contract Technical Management, Earned Value Management, EVM, Project Engineering, Risk Management, Concurrent Engineering, Verification, Test, Consultant, PMO
Software Engineer - 20 Years of Experience - Near 27330
Tags for this Online Resume: Benefits, IBM WebSphere, Insurance, Management, Microsoft, Microsoft Office, Application Server, Electronic Commerce, IBM AIX, IBM DB2 Database
